Status:
RECRUITING
Avacostar - (PASS)
Lead Sponsor:
Vifor Fresenius Medical Care Renal Pharma
Conditions:
ANCA-associated Vasculitis
Eligibility:
All Genders
18+ years
Brief Summary
The Avacostar PASS is a non-interventional, multi-national, prospective cohort study that will collect data from 2 cohorts of patients: those treated with avacopan for active severe AAV, and a second ...
Detailed Description
The Avacostar PASS is a non-interventional, multi-national, prospective cohort study that will collect data from 2 cohorts of patients: those treated with avacopan for active severe AAV, and a second ...
Eligibility Criteria
Inclusion
- Diagnosis of AAV (MPA or GPA), as determined by the Investigator according to their usual practice.
- Active, severe AAV at the time of commencing avacopan or non-avacopan SoC induction therapy, in the opinion of the Investigator.
- Age ≥18 years of either sex.
- Has provided written informed consent.
- Has commenced within the previous 6 months, or is planned to commence avacopan, cyclophosphamide or rituximab for the treatment of severe, active AAV outside of an interventional clinical study.
Exclusion
- • Concurrent participation in an interventional study, unless prospectively discussed and agreed with the Medical Monitor.
Key Trial Info
Start Date :
September 11 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05897684
Start Date
September 11 2023
End Date
December 1 2030
Last Update
January 31 2025
Active Locations (35)
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1
Charité University Medicine
Berlin, Germany
2
University Hospital of Cologne
Cologne, Germany
3
Municipal Hospital Dresden
Dresden, Germany
4
University Hospital Essen
Essen, Germany